(83 days)
The Gemini Standard and Mini Valves are utilized in the treatment of hydrocephalic patients. They are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneal cavity.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's instructions for use.
Prescription Use Only (Per 21 CFR 801.109)
The Gemini Standard and Mini Valves are contoured silicone elastomer valves substantially equivalent to legally marketed predicate devices used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valves incorporate an internal low, medium or high pressure valve assembly which is mounted distal to an integral pumping reservoir for proximal control of CSF flow. The devices also prevent retrograde flow. Integral occluders are incorporated on the proximal and distal ends of the valves. The occluders are designed to manually control the flushing or pumping of CSF proximally or distally. The devices are fitted with a polypropylene needle guard, designed to prevent needle puncture through the valve base during percutaneous injection. The devices contain an integral plastic connector on each end to simplify the attachment of the catheters during the clinical procedure. The devices do not contain any ferrous metal parts which would interfere with magnetic resonance imaging or computerized axial tomography.
The provided text is a 510(k) premarket notification for the Gemini Standard and Mini Valves, which are medical devices used for treating hydrocephalus. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a study with acceptance criteria and a detailed analysis of device performance against those criteria as would be typical for clinical studies evaluating new, non-substantially equivalent devices.
Therefore, the requested information cannot be fully provided from the given text. Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the document. The 510(k) submission model relies on comparing the new device to a predicate device, arguing that its functionality, design, placement, and use are substantially equivalent, rather than setting and meeting specific performance acceptance criteria through clinical trials for a novel device.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not present as there is no "test set" in the context of a clinical performance study described. The basis for the 510(k) is a comparison to predicate devices, not performance on a specific dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not present. Ground truth establishment is relevant for performance studies, which are not detailed in this 510(k) submission.
4. Adjudication Method:
This information is not present. Adjudication methods are used in clinical trials to resolve discrepancies in expert opinions for ground truth, which is not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not present. An MRMC study is a type of clinical trial that compares the performance of human readers with and without AI assistance. This document describes a medical device, not an AI algorithm, and does not include a comparative effectiveness study.
6. Standalone (Algorithm Only) Performance Study:
This information is not present. This is a medical device, not an algorithm, so a "standalone" algorithm performance study is not applicable.
7. Type of Ground Truth Used:
This information is not present. As no performance study is described, there's no mention of ground truth types (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set:
This information is not present. Training sets are relevant for machine learning algorithms, which are not the subject of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established:
This information is not present. Similar to point 8, this is not applicable to the device described in the document.
Summary of What Is Provided (Context for the 510(k)):
- Device Name: Gemini Standard and Mini Valves
- Intended Use: Treatment of hydrocephalic patients by shunting cerebrospinal fluid (CSF) from the lateral ventricles of the brain to the right atrium of the heart or the peritoneal cavity.
- Classification: Class II
- Predicate Devices: Heyer-Schulte NeuroCare Low-Profile Valves (LPV, Mini-LPV, ProfileVS) K802586A, and Heyer-Schulte NeuroCare NOVUS Standard and Mini Valves K961859.
- Basis for Equivalence: Substantially equivalent to predicate devices with respect to functionality, design, placement, and use in the neurosurgical arena.
- Device Features: Contoured silicone elastomer valves, internal low/medium/high pressure valve assembly, integral pumping reservoir, prevents retrograde flow, integral occluders (proximal and distal), polypropylene needle guard, integral plastic connectors, no ferrous metal parts (MRI/CAT compatible).
- Regulatory Mechanism: 510(k) premarket notification, demonstrating substantial equivalence.
In essence, the document serves as a regulatory submission and approval, stating that the new device is "substantially equivalent" to existing, legally marketed devices, rather than providing data from a clinical study on its performance against specific acceptance criteria.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).